Background
Kidney transplant candidates (KTCs) must provide informed consent to accept kidneys from increased risk donors (IRD), but poorly understand them. We conducted a multisite, randomized controlled trial to evaluate the efficacy of a mobile web application, Inform Me, for increasing knowledge about IRDs.
Methods
KTCs undergoing transplant evaluation at 2 transplant centers were randomized to use Inform Me after routine transplant education (intervention) or routine transplant education alone (control). Computer adaptive learning method reinforced learning by embedding educational material, and initial (Test 1) and additional test questions (Test 2) into each chapter. Knowledge (primary outcome) was assessed in person after education (Tests 1 and 2), and 1-week later by telephone (Test 3). Controls did not receive Test 2. Willingness to accept an IRD kidney (secondary outcome) was assessed after Tests 1 and 3. Linear regression Test 1 knowledge scores were used to test the significance of Inform Me exposure after controlling for covariates. Multiple imputation was used for intention-to-treat analysis.
Results
Two hundred-eighty-eight KTCs participated. Intervention participants had higher Test 1 knowledge scores (mean difference=6.61; 95% CI, 5.37–7.86) than control participants, representing a 44% higher score than control participants’ scores. Intervention participants’ knowledge scores increased with educational reinforcement (Test 2) compared to control arm Test 1 scores (mean difference=9.50; 95% CI, 8.27–10.73). After 1 week, intervention participants’ knowledge remained greater than controls’ (mean difference=3.63; 95% CI, 2.49–4.78) (Test 3). Willingness to accept an IRD kidney did not differ between study arms at Tests 1 and 3.
Conclusion
Inform Me use was associated with greater KTC knowledge about IRD kidneys above routine transplant education alone.
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Informed consent for organ transplantation and donation is an ethical obligation, legally required, and considered as part of the Patient's Rights Condition of Medicare Participation for hospitals. National policy-makers recommend that informed consent forms and patient education materials be written at a low reading level (5th-8th grade level) to facilitate patient comprehension. We assessed reading levels of informed consent forms (CFs) for adult organ transplant recipients and living organ donors across US transplant centers. CFs were analyzed using three measures of reading level: Lexile Measure, Flesch-Kincaid Grade Level, and the Gunning Fog Index. Of active transplant centers contacted (N=209), 75 (36%) sent a total of 332 CFs. CFs were written, on average, at the college level, which is a considerably higher reading level than the standards set by policy-makers. CF reading levels were negatively correlated with transplant center volume (r=-0.119; p<0.03). CFs for intestine transplantation and for evaluation/listing were the easiest to read, while consent forms for liver transplantation/donation and pre-transplant agreements were the most difficult to read. Reducing CFs' reading level may help to increase patient comprehension for adequate informed consent.
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